solaris peripheral pmcf trial

Conditions: Peripheral Arterial Disease; Iliac Artery Stenosis; Common Femoral Artery Stenosis

Summary: the objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the solaris vascular stent graft (scitech) in clinical settings when used according to the indications of the ifu.


Eligibility criteria:
inclusion criteria: * corresponding to the ifu indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions. * patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator) * patient presenting a score from 2 to 5 following rutherford classification * patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study * patient is \>18 years old * patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * the target lesion is either a modified tasc-ii class a, b, c or d lesion. * the target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation * there is angiographic evidence of a patent common and deep femoral artery exclusion criteria: * pta is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter) * presence of an aneurysm immediately adjacent to the site of stent implantation * stenosis distal to the site of stent implantation * lesions in or adjacent to essential collaterals(s) * lesions in locations subject to external compression * heavily calcified lesions resistant to pta * patients with diffuse distal disease resulting in poor stent outflow * patients with a history of coagulation disorders * patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy * fresh thrombus formation * patients with known hypersensitivity to the stent material (l605) and/or ptfe * the target lesion is either a modified tasc-ii class b or d lesion with aortic or common femoral lesion involvement. * previously implanted stent(s) at the same lesion site * reference segment diameter is not suitable for the available stent design * untreatable lesion located at the distal outflow arteries * use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure * patients refusing treatment * patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site * perforation at the angioplasty site evidenced by extravasation of contrast medium * patients with a history of prior life-threatening contrast medium reaction * patients with uncorrected bleeding disorders * female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * life expectancy of less than twelve months * any planned surgical intervention/procedure within 30 days of the study procedure * any patient considered to be hemodynamically unstable at onset of procedure * patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.